MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB; CATHETER, BILIARY, DIAGNOSTIC

Model Number	32900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suture broke.An 8.3/25 expel drainage catheter with twist-loc hub was selected for use and attached to the patient's right chest.During procedure, the drainage catheter was inserted.After positioning, when it was pulled, it was noted that the suture broke.The device was removed together with the suture and nothing was left inside the patient.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was returned for analysis, the metal cannula is loaded in the catheter and the metal cannula is bent at middle section.Additionally, the suture string was observed broken at distal section.No other anomalies or damages were encountered.Finally, the metal cannula was able to unloaded from the catheter without issues.
Event or Problem Description
It was reported that the suture broke.An 8.3/25 expel drainage catheter with twist-loc hub was selected for use and attached to the patient's right chest.During procedure, the drainage catheter was inserted.After positioning, when it was pulled, it was noted that the suture broke.The device was removed together with the suture and nothing was left inside the patient.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.

• Brand Name: EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11957717
• Report Number: 2134265-2021-06925
• Device Sequence Number: 17029869
• Product Code: FGE
• UDI-Device Identifier: 08714729860587
• UDI-Public: 08714729860587
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K141335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: 32900
• Device Catalogue Number: 32900
• Device Lot Number: 0026353537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1